On 31 December 2018, the Government issued Decree No. 169/2018/ND-CP (Decree No. 169) amending and supplementing certain provisions of Decree No. 36/2016/ND-CP relating to the management of medical devices (Decree No. 36). Decree No. 169 took effect on 31 December 2018. Below are some notable changes related to the registration of medical devices:
1. Fast track approval for product registration in the following cases:
a) Medical devices that have been in circulation in at least 02 of the following countries: Japan, Canada, Australia, USA, EU member countries. In this case, in addition to those documents required to be within the registration dossier for the normal approval process, the applicant is required to submit at least 01 Certificate of Free Sales ("CFS") issued by one of the following countries: EU member countries, Japan, Canada, Australia, or the USA.
b) Medical devices in circulation within Vietnam prior to 31 December 2018 and that meet the following conditions:
- Have been in circulation for at least 03 years within 05 years prior as to the date of application;
- There is no warning information regarding the quality and safety of such medical devices
In this case, in addition to those documents required to be within the registration dossier for the normal approval process, the applicant is required to submit at least 03 supply contracts relating to such medical devices to health facilities in Vietnam. They must then receive a confirmation letter from those health facilities confirming that such medical devices do not have any warning information relating to the quality and safety of the devices for usage.
2. New requirement of Certificate of Free Sales for Class A medical devices:
Compared with Decree No. 36, among other changes, Decree No. 169 adds the new requirement of a CFS for imported medical devices under Class A in the dossier of announcement of applicable standard for Class A medical devices.
3. New requirement of Common Submission Dossier Template (CSDT) for Class B, C and D medical devices:
Compared with Decree No. 36, among other changes, Decree No. 169 adds a new requirement of CSDT in accordance with ASEAN's treaties on medical devices. However, this new requirement will only be applied from 1 July 2020.
If you would like to discuss the potential impacts of Decree No. 169 on your business and the necessary steps going forward, please do not hesitate to contact us.